Kornimate/medical-research-clean huggingface dataset:
cynara scolymus extract for treatment of diabetes mellitus type 2

Conditions: Diabetes Mellitus, Type 2

Summary: edible parts of the artichoke plant (cynara cardunculus, cynara scolymus) are traditionally known in folk-medicine for lipid lowering and choleretic effects. furthermore, antidiabetic effects are described. in the past year's research attributed health promoting effects to the main active compounds chlorogenic acid, luteolin and apigenin. present literature indicates potential antidiabetic effects by different mechanisms like downregulation of gluconeogenesis, increased glp-1 secretion and modification of insulin signalling. up to now only few human clinical trials provide insufficient data to conclude the therapeutic potential of cynara scolymus extract in the treatment of type 2 diabetes. the primary objective is to evaluate the antidiabetic effect and the mechanisms of glucose lowering by a 12-week treatment with a highly-standardized extract of cynara scolymus in subjects with diabetes mellitus type 2 compared to placebo.


Eligibility criteria:
inclusion criteria: * male or female ≥18 years old. * diagnosis of diabetes mellitus type 2 ≥ 90 days prior to screening * hba1c-level between 6.5-9% * body mass index of ≥ 28 kg/m2 * stable daily dose (for at least 30 days) of 1-3 oral antidiabetic drug (metformin, sulfonylurea, sglt-2 inhibitor, thiazolidinedione or dpp-iv-inhibitor) exclusion criteria: * subjects with diabetes mellitus type 1 or history of ketoacidosis, * uncontrolled diabetes, defined as fasting plasma glucose ≥20mmol/l or recurrent hypoglycemia (defined as capillary glucose values ≤3.5mmol/l) * use of insulin or glp-1-receptor agonists * women wanting to become pregnant * pregnant or breast-feeding women * known hepatic disorder * severe renal insufficiency (gfr ≤30ml/min) * history of inflammatory bowel disease * history of gastric bypass or gastric sleeve surgery * anticoagulation with vitamin k-antagonists
immunogenicity of a single dose of gsk biologicals' boostrix™ in infants prior to primary pertussis vaccination, when administered to pregnant women as per routine practice in bogota, colombia

Conditions: Diphtheria-Tetanus-Acellular Pertussis

Summary: the purpose of the study is to support the recommendation of vaccination of all pregnant women in colombia with diptheria, tetanus and pertussis (dtpa) by studying the transfer of pertussis specific igg antibodies from mother to the child.

this study will assess the immunogenicity in infants (at birth and just prior to primary pertussis vaccination \[i.e. diphtheria, tetanus and pertussis \[dtp\] vaccination\] administered at 8 weeks of age), of a single boostrix booster dose administered to their mothers during the second or third trimester as per routine practice in bogota, colombia.

Eligibility criteria:
inclusion criteria: criteria applicable at screening (before the birth of the infant): * male or female infants whose mothers have received boostrix during their current pregnancy, as per routine practice. * infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol. * written informed consent obtained from both parents of the infant. criteria applicable at enrolment (after the birth of the infant): * confirmation of written informed consent obtained from both parents of the infant at the time of screening. * infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol. exclusion criteria: criteria applicable at screening (before the birth of the infant): * infants whose parents are below the legal consenting age of the country. * infant's whose mother has multiple pregnancies. * infant's whose mother has any confirmed or suspected immunosuppressive or immunodeficient condition (including positive infection with human immunodeficiency virus \[hiv\]), based on medical history, physical examination or positive test result. * infant's whose mother is concurrently participating in another clinical study, at any time during the study period, in which the infant's mother has been or will be exposed to an investigational or a non-investigational vaccine/product. criteria applicable at enrolment (after the birth of the infant): * child in care. * in case of multiple births. * infants with any confirmed or suspected immunosuppressive or immunodeficient condition , based on medical history, physical examination or positive test result. * infants who are concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

Keywords: infants cord blood sample acellular pertussis boostrix colombia pregnant women
early initiation of post sternotomy cardiac rehabilitation

Conditions: Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease

Summary: the main objective of this trial is to investigate the effects of starting exercise rehabilitation earlier than current practice after coronary artery bypass graft(cabg) or aortic/mitral valve replacement (vr) surgery.

the trial will compare health improvements after cardiac rehabilitation, (cr) between participants randomly allocated to one of two groups: an early cr group starting exercise after 2 weeks, and a usual care group starting at 6 weeks. it will also collect information on the financial cost of earlier cr to both the health service and the patients. all primary and secondary outcome measures will be taken at baseline (1 week) and repeated at the start and end of 8 weeks exercise rehabilitation program (2 and 10 weeks from baseline for the early group, 6 and 14 weeks in the usual care group respectively) and at 12 months follow-up.

Eligibility criteria:
inclusion criteria: * coronary artery bypass graft, and mitral/aortic valve replacement patients recovering from sternotomy procedure eligible for cardiac rehabilitation * able to provide written informed consent * male or female 18 years of age or greater exclusion criteria: * patients with any of the following: * serious cardiac arrhythmias * current neurological disorders or previous cerebral vascular accident with residual neurological deficit significant enough to limit exercise * enrolled on another clinical trial that involved exercise * unable to enroll for duration of study * patients who are unable to provide written consent. * patients under the age of 18 or over the age of 90.

Keywords: cardiac rehabilitation
glycaemic alterations in icu

Conditions: Diabetes Mellitus

Summary: to quantify the local prevalence of diabetes mellitus in critically ill patients. to understand whether a correlation does exist between premorbid glycaemic control and glycaemic status in icu. a subgroup analysis will be conducted to investigate whether a relationship does exist between neuron specific enolase levels and glycaemic disorders.

the aim of this study is to determine the local prevalence of critical illness-associated hyperglycaemia (ciah) and recognised and unrecognised diabetes, as well as to evaluate how premorbid glycaemia impacts the relationship between three glycaemic domains and mortality. the investigators will calculate the time in range (tir, 70-180 mg/dl) and evaluate distribution of percentage time in range for non-diabetics and diabetics patients, in order to understand the association between tir and survival in both groups of patients (patients with diabetes and patients without diabetes). in view of the potential adverse effects of hyperglycaemia, hypoglycaemia and glycaemic variability on the brain, the investigators will dose neuron specific enolase in critically ill patients. the aim is to define if a biochemical correlation does exist between critically ill dysglycaemia and nse plasma concentration.

Eligibility criteria:
inclusion criteria: * icu patients * expected icu length of stay \> 48 hours exclusion criteria: * age \<18 years * icu length of stay \<48 hours * diabetic ketoacidosis * hyperosmolar nonketonic hyperglycaemia syndrome * pregnancy * hypoglycaemic coma * acute or acute on chronic liver failure, liver transplantation or end-stage liver disease.
a study using swedish registries to find out how many people with type 2 diabetes had cardiovascular disease and started treatment with empagliflozin between 2015 and 2017

Conditions: Type 2 Diabetes Mellitus

Summary: this study aims to describe the prevalence of type 2 diabetes mellitus (t2dm) patients with established cardiovascular disease (cvd) according to the (empagliflozin) cardiovascular outcome event trial in type 2 diabetes mellitus patients (empa-reg outcome (ero)) study definition in a swedish population. the aim was also to describe the prevalence of established cvd according to ero study definition in patients with t2dm who initiates treatment with empagliflozin


Eligibility criteria:
inclusion criteria population 1: 'prevalence of a history of cardiovascular disease (cvd) among persons with type 2 diabetes mellitus (t2dm) who were alive on 31 december 2017' : * diagnosed with t2dm in sweden * alive on 31 december 2017 * at least one registration in the swedish national diabetes register (ndr) * each patient provides informed consent for inclusion in the register population 2: 'prevalence of a history of cvd among persons with type 2 diabetes who started empagliflozin treatment between 1 january 2015 and 31 december 2017': * diagnosed with t2dm in sweden * alive on 31 december 2017 * initiated on empagliflozin between 1 january 2015 and 31 december 2017 * at least one registration in the ndr * each patient provides informed consent for inclusion in the register exclusion criteria: none
enhancing functional hand recovery through nerve reconstruction in total brachial plexus birth injury

Conditions: Brachial Plexus Injury

Summary: interpreting the published outcomes of hand function in total bpbi is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower trunk using the best available root. in this paper, investigators outline the details of the strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes.

managing total bpbi cases is complex because surgical reconstruction must address the restoration of shoulder, elbow, and hand functions. in cases where multiple nerve root avulsions are present, prioritizing which functions to reinnervate shoulder, elbow, or hand becomes a critical decision. while attempts to restore hand function in adults with total brachial plexus lesions have yielded disappointing results, it has been shown that restoring hand function in infants with bpbi is more promising due to their enhanced neuro-regenerative capacities. interpreting published outcomes of hand function in total bpbi is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. various hand function scales that measure the individual joint movements or the global function of the hand and wrist have been used in the assessment of the outcomes, but none has quantitated the recovery of the intrinsic muscles of the digits or thumb. furthermore, it is well-documented that the recovery of hand function can be a prolonged process, often extending up to eight years before reaching a plateau. the majority of the published studies have typically reported outcomes based on a minimum follow-up period of two years, which may not provide sufficient time to assess the full extent of hand function recovery. investigators have followed a well-defined protocol for the surgical reconstruction of total bpbi with the primary objective being restoration of hand function through reinnervation of the lower trunk followed by restoration of elbow and shoulder functions through innervation of the upper trunk. in this paper, investigators outline the details of the surgical strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes. furthermore, investigators explore and identify the factors that may significantly impact the recovery process.

Eligibility criteria:
inclusion criteria: * patients who underwent brachial plexus exploration and reconstruction for total obpp. who have reached at least four years of follow-up exclusion criteria: * excluding children who had selective distal neurotization for restoration of specific functions without brachial plexus exploration or who had secondary procedures to the hand.
xanthohumol as an adjuvant in the treatment of septic shock

Conditions: Septic Shock; Pneumonia; ARDS

Summary: septic shock (ss) is a life-threatening condition resulting from excessive inflammatory response to bacterial, viral or/and fungal infections. it is associated with dysregulation of the immune system, activation of immune cells, and massive release of cytokines, commonly known as the cytokine storm (cs). the clinical manifestations of ss depend on the initial site of infection. however, the classic symptoms are associated with severe dysfunction of the respiratory and cardiovascular systems, which are observed from the early phase. respiratory insufficiency frequently requires different forms of oxygen supplementation, including mechanical ventilation and even extracorporeal oxygenation. the severity of respiratory and other organ dysfunction depends on the inflammatory response to the infection and circulating toxins, which correspond to excessive cytokine release. in the past years, several studies documented that reduction of ss-related inflammatory response and cs improved organ function and alleviated the clinical course of ss. unfortunately, an effective strong anti-inflammatory without side effects medications has not yet been found. therefore, the use of natural anti-inflammatory and antioxidant substances seems very promising. xanthohumol (xn) is a natural prenylated chalcone extracted from the female inflorescences of hop cones (humulus lupus) and possesses strong anti-inflammatory and antioxidant properties. it is widely used as a supplement to diet. xanthohumol inhibits cs and has been showed to be an effective medication for reducing the severity of lung injury. it has been documented that xn inhibits proinflammatory pathways in a different manner. a decrease in cytokine production and release can affect endothelial function and correct inflammatory-related vascular hyperpermeability, reducing uncontrolled water shift to extravascular space and then tissue edema. clinical observation showed that administration of xn alleviated clinical course, improved respiratory function, and reduced mortality in critically ill covid-19 patients. xanthohumol is safe and well tolerated by humans, and no adverse effects have been reported yet. based on its strong anti-inflammatory and antioxidative properties, it can be speculated that the use of xn can effectively reduce the inflammatory response and improve the clinical course in ss patients.


Eligibility criteria:
inclusion criteria: * a septic shock in the early, acute phase, * respiratory insufficiency required mechanical ventilation with pao2/fio2 \< 150, * bacterial infection, * procalcitonin higher than 5 ng/ml and interleukin 6 higher than 100 pg/ml, * no allergy to hops or their derivatives, * hemodynamic instability requiring vasopressor infusions exclusion criteria: * lack of agreement * septic shock treated for more than 1 day, * history of severe chronic cardiac, pulmonary and/or liver diseases

Keywords: septic shock inflammation xanthohumol adjuvant endotheliopathy ards
validation of the small intestine microbiome aspiration (simba) capsule

Conditions: Proof of Concept; Irritable Bowel Syndrome

Summary: prospective, open label trial to establish the ability of the simba capsule to accurately obtain a sample from the small bowel of participants with ibs (10 constipation-predominant (ibs-c) and 10 diarrhea-predominant (ibs-d)) and healthy participants (n=10). the accuracy of targeting the small bowel will be established by visual confirmation via x-ray. the clinical utility of the collected sample will be evaluated by analysis with samples obtained by the current gold standard (duodenal aspirate), as well as stool analysis and lbt.


Eligibility criteria:
inclusion criteria 1. aged between 18 and 70 years. 2. diagnosis of ibs by rome 4 criteria (ibs groups) or no previous diagnosis of ibs or suspected ibs (control group). 3. ability to understand and provide informed consent. 4. ability and willingness to meet the required schedule and study interventions. 5. no planned change in diet or medical interventions during the study duration. 6. adequate mobility to transfer repeatedly between x-ray (standing or lying), and waiting (sitting). 7. willing and able to undergo a sedated esophagogastroduodenoscopy (egd) with aspirate and brushing. exclusion criteria 1. prior gastrointestinal disease, surgery, or radiation treatment which, in the investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion (particular diseases which would be assessed on a case-by-case basis would include, achalasia, eosinophilic esophagitis, crohn's disease, cancer diagnosis or treatment within the past year, or previous esophageal, gastric, small intestinal, or colonic surgery. appendectomy or cholecystectomy more than 3 months prior to enrollment are acceptable). 2. use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (ppi, h2ra). 3. history of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule. 4. females of childbearing age who are not practicing birth control and/or are pregnant or lactating. 5. no antibiotics, or colon cleanses/bowel prep for 2 weeks. 6. \< 2 bowel movements per week (control group).
carotid atherosclerotic plaque load and neck circumference

Conditions: Atherosclerosis of Artery; Metabolic Syndrome; Machine Learning

Summary: the aim of this study is to establish a deep learning model to automatically detect the presence and scoring of carotid plaques in neck cta images, and to determine whether this model is compatible with manual interpretations.

modeling cta images for carotid artery segments with deep learning method and automatic carotid plaque presence and scoring will be useful and beneficial in clinical practice. the aim of this study is to establish a deep learning model to automatically detect the presence and scoring of carotid plaques in neck cta images, and to determine whether this model is compatible with manual interpretations.

Eligibility criteria:
inclusion criteria: * 18 years or older * having cranial cta withdrawn * having blood lipids, hba1c, blood glucose, ast, alt measured in 3 months before and 3 months after cranial cta exclusion criteria: * thyroid disease * having had neck surgery * use of corticosteroids for more than 6 months * presence of lymph nodes in the anterior neck * hypertrophy of neck muscles

Keywords: atherosclerosis of artery metabolic syndrome machine learning
visual function changes after intraocular pressure reduction

Conditions: Glaucoma

Summary: during the glaucomatous disease process, subpopulations of cells may be dead, damaged or healthy. visual function changes could be observed due to a recovering of the suffering ganglion cells after the intraocular pressure reduction. this study aims at evaluating the correlation between intraocular pressure reduction and visual function changes in glaucoma patients after using antiglaucoma medications.

primary open angle glaucoma patients without use of antiglaucoma medications will be enrolled in this study. after inclusion, the patients will randomly receive one of three antiglaucoma medications (timolol maleate 0,5%, brimonidine tartrate 0,2% or travoprost 0,004%) in one randomly selected eye. the patients will be evaluated with goldmann applanation tonometry, visual acuity test, contrast sensitivity test, visual quality perception test (visual analogue scale) and standard automated perimetry before and after 4 weeks of glaucoma treatment onset.

Eligibility criteria:
inclusion criteria: * primary open angle glaucoma * intraocular pressure greater than 21 mmhg exclusion criteria: * best corrected visual acuity (bcva) worse than 20/80 * significant media opacity * history of steroid use

Keywords: intraocular pressure contrast sensitivity visual function
study to evaluate recovery from postoperative pain after sleep apnea surgery

Conditions: Sleep Apnea, Obstructive

Summary: the purpose of this study is to assess whether tonsillectomy and uppp performed using the study device to treat obstructive sleep apnea (osa) symptoms in adults is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection.

this prospective clinical study is designed to assess whether tonsillectomy and uppp performed using the study device to treat osa symptoms in an adult population is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection. the amount of post-operative pain will be assessed daily over the 21-day post-operative recovery period using two general measures: 1) self-reported pain intensity and 2) self-reported pain medication administration, including frequency of use and dose. further, timing of self-medication will be analyzed separately.

Eligibility criteria:
inclusion criteria: * subject is \> or = 18 years of age * subject has positive diagnosis of obstructive sleep apnea confirmed by polysomnographic study * subject is a surgical candidate for uppp and tonsillectomy with or without tongue base somnoplasty * subject signs irb-approved informed consent form * subject is willing and able to complete required follow-up. exclusion criteria: * subject has had a previous tonsillectomy * subject's rdi \>40 * subject has a history of chronic use of narcotic pain medications * subject is unable to take liquid opioid analgesics * subject requires additional surgical procedures (such as nasal septoplasty or fess) within 28 days of enrollment

Keywords: obstructive sleep apnea pain uppp tonsillectomy narcotics